Nearly two-thirds of adolescents saw clinically meaningful improvement in attention following treatment
Improvements were nearly three times as large as those in the pivotal trial that supported EndeavorRx’s FDA authorization for children with ADHD ages 8-12
Akili has filed with FDA for potential EndeavorRx label expansion
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, is presenting pivotal trial data on EndeavorRx® (AKL-T01) in adolescents with attention-deficit/hyperactivity disorder (ADHD) at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami Beach on May 31, 2023, and at the Elevate Psych Congress in Las Vegas on June 2-3, 2023. The poster presentations highlight results of Akili’s STARS-ADHD-Adolescents label expansion trial evaluating the efficacy and safety of EndeavorRx in adolescents ages 13-17 with ADHD.
The multi-center open-label study enrolled 162 adolescents ages 13-17 with inattentive or combined-type ADHD. After four weeks of treatment with EndeavorRx, trial participants saw significant improvements across a wide range of clinical outcomes, including in their attention and ADHD-related symptoms.
“The data being presented expand the evidence supporting the safety and efficacy of EndeavorRx to improve attention and functioning in adolescents with ADHD,” said Scott Kollins, Ph.D., chief medical officer of Akili. “Teenagers have been significantly impacted by our current mental health crisis, yet face substantial challenges in accessing effective treatment for ADHD. With our ongoing label expansion strategy, we aim to advance ADHD care management for people of all ages to break down these barriers and get treatment into the hands of patients in need.”
In the STARS-ADHD-Adolescents trial, EndeavorRx demonstrated a statistically significant improvement in adolescents’ attention function as measured by a change in the Attention Comparison Score (ACS) of the FDA-cleared Test of Variables of Attention (TOVA®), the trial’s predefined primary efficacy endpoint. Nearly two-thirds (66%) of adolescents met the prespecified definition of clinical response on the TOVA-ACS. The magnitude of improvement in attention function in teenagers was nearly three times larger than what was observed in the STARS-ADHD pivotal trial in 8-12 year olds that served as the basis for EndeavorRx’s FDA authorization. The mean change from baseline on the TOVA-ACS in adolescents was 2.6 (SD=3.8; P < 0.0001) as compared to 0.93 (p<0.001) in 8-12 year olds. In exploratory responder analyses, 24.7% of participants no longer had a measurable attention deficit following treatment, achieving a TOVA-ACS of at least 0, which is in the normative range.
There were also consistent clinical benefits seen across a range of secondary measures of ADHD-related symptoms and functioning. Adolescents using EndeavorRx saw significant improvement in the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores (p<0.0001 for both). ADHD-RS is a clinician-administered questionnaire which uses information collected from the child's caregiver. A prespecified responder analysis also showed that 27.1% of adolescents in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS following EndeavorRx treatment, a finding similar to the STARS-ADHD trial in children 8-12 (24%). Statistically significant improvements were also observed for parent and child ratings of attention improvement, as well as parent ratings of function across a number of domains, including peer relationships, academic functioning, behavioral functioning, homework functioning, and self-esteem.
In the study, approximately half of the teenagers used EndeavorRx by itself and the other half used it in conjunction with stimulant medication. The benefits of EndeavorRx were comparable whether it was used alone or along with stimulants.
Consistent with the favorable safety profile reported in previous studies of EndeavorRx, the treatment was shown to be safe in this study, with no serious adverse events observed. A total of 4 participants (2.5%) experienced any adverse events, all of which were anticipated and mild or moderate, including: frustration tolerance decreased (3 participants) and headache (1 participant).
EndeavorRx is currently authorized for use in 8-12 year olds with ADHD. Based on these new data, Akili has filed with FDA to expand its current EndeavorRx label to include 13-17 year olds. In May, Akili announced topline data from a successful pivotal study of EndeavorRx in adults with ADHD 18 years of age and older, demonstrating that improvements in both objective measures of attention and clinical outcomes surpassed those seen in both pediatric and adolescent patient populations.
EndeavorRx Indication and Overview
EndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, the Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.
Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
These forward-looking statements include, without limitation, statements in this press release related to: the potential expansion of our current pediatric market through our regulatory filing with FDA to seek a potential label expansion for EndeavorRx in ADHD to include adolescents ages 13-17. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: the risk that prior results, such as signals of efficacy or safety observed from clinical trials will not continue or be repeated in EndeavorRx or our ongoing or planned clinical trials, or will be insufficient to support regulatory submissions or support or maintain marketing approval or label expansion approval in the United States or other jurisdictions, or that long-term adverse safety findings may be discovered; the risk that our products will not be further developed or commercialized successfully; the timing and results expected from our and our partners’ clinical trials and our reliance on third parties for certain aspects of our business; our ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in our current filings and any subsequent filings made with the Securities and Exchange Commission (SEC). We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof and should not be relied upon as representing the company’s views as of any subsequent date. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.